NCT07384988

The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years

The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shaoxing Maternity and Child Health Care Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

Dental anxiety (DA) is highly prevalent among children undergoing dental procedures, with 50-80% experiencing fear that disrupts treatment and exacerbates oral health outcomes. While nitrous oxide (N₂O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy in reducing pediatric fear and anxiety scores.

Detailed description

This study adopted a randomized controlled trial (RCT) design, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure scientific rigor, reliability, and transparency.The sample size was calculated based on previous literature and preliminary pilot study results. Referring to the standard deviations of dental fear and anxiety scores in similar studies, the significance level (α) was set at 0.05, and the power (1 - β) was set at 0.85 (90% power). With an effect size of 0.4, the study anticipated significant differences in fear and anxiety scores between the experimental and control groups. Using statistical formulas and considering practical constraints, the estimated sample size required for each group was no fewer than 58 participants to ensure sufficient statistical power.

Conditions

• Dental Anxiety

Interventions

Type	Name	Description
DRUG	Nitrous Oxide Sedation	After the child was seated in the dental chair, an appropriately sized nasal mask was selected to ensure a secure fit without leakage. The child initially inhaled 100% oxygen for 3-5 minutes to adapt to the breathing pattern and eliminate nitrogen from the lungs. Nitrous oxide was then introduced at an initial concentration of 10%-15%, with adjustments made in increments of 5%-10% based on the child's anxiety level, treatment stimuli, and vital signs. Each adjustment was followed by 1-2 minutes of observation until the desired level of sedation was achieved.
BEHAVIORAL	psychological support	gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate.

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-08-31
• Completion: 2024-09-08
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: China